Core Insights - Axsome Therapeutics has experienced a significant stock increase of approximately 75% over the past 12 months, outperforming the S&P 500, which rose by 15% during the same period [1] - The company is set to report its quarterly results on February 23, 2026, which will include numbers for the last three months of 2025 and full-year results [2] Financial Performance - In its most recent earnings report for the period ending September 30, 2025, Axsome's revenue increased by 63% year-over-year, totaling $171 million, while the net loss decreased from $64.6 million to $47.2 million [5] - Despite the strong earnings, the stock price did not see a significant increase following the report, rising less than 2% a week later [6] Regulatory Developments - A major catalyst for the stock occurred on December 31, 2025, when regulators granted priority review for the company's Alzheimer's drug, AXS-05, with a target action date of April 30, 2026, leading to a 23% jump in shares on the announcement day [6] Market Valuation - Axsome's market capitalization has reached approximately $9.4 billion, but the company remains unprofitable and trades at a price-to-sales multiple of 16, indicating a potentially expensive investment [7] - The company's growth stage suggests that regulatory news may have a more significant impact on share price than earnings results, as evidenced by the stock's reaction to the AXS-05 news [8]

Core Insights - Relmada Therapeutics has reported positive initial Phase 2 proof-of-concept data for NDV-01, showing a 90% overall response rate in non-muscle invasive bladder cancer (NMIBC) [1][4] - The company plans to initiate a Phase III registration trial for NDV-01 in the first half of 2026 and a Phase 2 study for sepranolone in Prader-Willi syndrome in the same timeframe [1][4] Pipeline Highlights - **NDV-01**: A sustained-release intravesical formulation of gemcitabine and docetaxel targeting high-grade NMIBC with a U.S. market opportunity of approximately 600,000 prevalent cases. The recent data shows a 90% overall response rate and 100% complete response in carcinoma in situ [5][10] - **Sepranolone**: A first-in-class GABAA Modulating Steroid Antagonist targeting disorders linked to excess GABAergic activity, with an estimated U.S. prevalence of 20,000 patients for Prader-Willi syndrome. A Phase 2 study is being prepared for initiation [5][11] Financial Results - For Q1 2025, the company reported a net loss of $17.5 million or $0.58 per share, compared to a net loss of $21.8 million or $0.72 per share in Q1 2024 [14][21] - Research and development expenses were $11.9 million, down from $13.3 million in Q1 2024, reflecting reduced trial costs [14][20] - Cash, equivalents, and short-term investments totaled $27.1 million as of March 31, 2025, down from $44.9 million at year-end 2024 [14][18]